Hybrid: Novato

Position Summary:

• The company is seeking a temporary contractor to support execution of a global material specification remediation program associated with regulatory commitments and CAPA activities.
• The contractor will work closely with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements.
• This role will provide critical support to accelerate regulatory commitments while enabling Material Sciences personnel to remain focused on strategic product and manufacturing priorities. The position will support specification updates, technical data gathering, compendial comparisons, document management, change control execution, and cross-functional implementation activities.

Key Responsibilities

Specification Remediation

• Review existing raw material specifications against current compendial requirements.
• Compare USP, Ph. Eur., JP, ACS, and supplier specifications where applicable.
• Support revision of excipient, chemical, and process material specifications.
• Compile technical justification packages and supporting rationale for specification updates, where appropriate.

Change Control & CAPA Support

• Support initiation and execution of change controls related to specification updates.
• Coordinate impact assessments from affected functional groups.
• Track implementation progress and CAPA milestones.
• Assist with closure documentation and inspection readiness activities.

Data Management & Documentation

• Maintain specification inventories and implementation trackers.
• Generate summary reports and status dashboards.
• Verify technical data consistency across specifications and supporting documents.
• Ensure document formatting aligns with approved specification templates.

Cross-Functional Coordination

• Work with Material Sciences, Quality Systems, Quality Control, Regulatory Affairs, Supply Chain, Manufacturing, and Procurement.
• Follow up with SMEs regarding impact assessments and outstanding actions.
• Support meeting preparation and action item tracking.

Inspection Readiness

• Assemble supporting documentation for regulatory inspections and CAPA effectiveness reviews.
• Support ongoing alignment of specifications with compendial and regulatory expectations.

Required Qualifications

• BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 3–4 years of experience in pharmaceutical manufacturing, quality, technical services, material sciences, or regulatory compliance.
• Experience working with GMP documentation.
• Strong technical writing and document revision skills.
• Familiarity with change controls, CAPAs, and deviation systems.
• Knowledge of pharmacopeial standards (USP, EP, JP).

Preferred Qualifications

• Experience with raw material specifications and supplier quality systems.
• Understanding of excipient and chemical control strategies.
• Experience supporting regulatory inspections or remediation programs.
• Familiarity with Veeva, document management systems, and electronic quality systems.
• Ability to independently manage multiple workstreams and priorities.

Success Metrics

• Specification revisions completed on schedule.
• Change control support delivered to meet CAPA milestones.
• Impact assessments and implementation activities tracked to completion.
• Inspection-ready documentation maintained.

The hiring range for this position is $52 to $62.06 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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